SOP for Storage and Labeling of Raw and Packing Materials

1.0 Purpose
1.1 To establish a procedure for storage and labeling of raw materials and packing materials in RM area

2.0 Scope
2.1 Applicable to all raw and packing materials used in the manufacturing of drug product facility.

3.0 Responsibility
3.1 The Head of Quality Assurance (QA) ensures the implementation of this procedure.

4.0 Procedure
4.1 Purchase raw and packing materials from approved vendors.
4.2 After purchase, ensure approved materials kept in designated areas within the raw material stores. Ensure primary packing materials are double wrapped.
4.3 Store materials on respective shelves according to size and type, avoiding the inter-mixing of different materials.

5.0 Area Division and Identification for Storage and Labeling
5.1 Use color-coded plates for material identification:
– Green: Approved materials
– Yellow: Under test materials
– Red: Rejected materials

5.2 Label materials with the following information:
– Item/Material Name
– Date of Receipt
– Supplier Name
– Lot Number- Quantity
– Acceptance A.R. Number
– Material code , SAP batch no

5.3 Prevent inter-mixing by storing different lots and materials separately.

6.0 Precautions
6.1 Ensure all documents are approved and controlled before issuance to user departments.

7.0 Records
7.1 Maintain an issuance record for all the issued materials